AzTrials
AzTrials

LeukemiaPhase 1NCT00064233

BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate

A Phase 1 study testing dasatinib in people with Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
dasatinib
How many people
42 participants
Where
1 siteUnited States
Study dates
Nov 2003to Oct 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Philadelphia chromosome positive, chronic phase chronic myelogenous leukemia (CML) meeting all of the following criteria*:
  • Less than 15% blasts in peripheral blood and bone marrow
  • Less than 20% basophils in peripheral blood
  • Less than 30% blasts and promyelocytes in peripheral blood and bone marrow
  • Platelet count at least 100,000/mm^3 NOTE: *Patients who previously met the criteria for accelerated phase or blast phase CML, responded to treatment, and currently meet the criteria for chronic phase CML are eligible
  • Primary or acquired hematologic resistance to imatinib mesylate OR intolerance to imatinib mesylate defined as follows:
Show all 52Show fewer
  • Primary hematologic resistance is defined as failure to reach complete hematologic response (CHR) with a dose of 400 mg/day continued for at least 3 months
  • Patients with hematological progression (i.e., WBC at least 10,000/mm^3 and rising consistently on at least 2 consecutive measurements obtained at least 14 days apart) while receiving imatinib mesylate of 400 mg/day are eligible if they have received less than 3 months of therapy
  • Acquired hematologic resistance is defined as achieving a CHR, but subsequently developing a rising WBC to at least 10,000/mm^3
  • WBC must be at least 10,000/mm^3 and rising on at least 2 measurements obtained at least 14 days apart with at least 1 of these measurements greater than 15,000/mm^3
  • Intolerance is defined as having discontinued imatinib mesylate due to nonhematologic toxicity of any grade
  • CD4^+ T-cell count at least 350/mm^3
  • 18 and over
  • ECOG 0-1
  • Life expectancy, At least 6 months.
  • Hepatic
  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.0 times upper limit of normal (ULN)
  • Renal
  • Creatinine no greater than 1.5 times ULN
  • Potassium normal*
  • Magnesium normal*
  • Serum calcium or ionized calcium at least lower limit of normal NOTE: *Patients with low levels may be repleted to be eligible
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month before, during, and 1 month after study participation
  • More than 14 days since prior interferon
  • More than 14 days since prior cytarabine
  • More than 3 days since prior hydroxyurea
  • More than 28 days since other prior investigational or antineoplastic agents
  • More than 7 days since prior imatinib mesylate
  • At least 5 days or 5 half-lives since prior medications that inhibit platelet function, including the following:
  • Aspirin
  • Dipyridamole
  • Epoprostenol
  • Eptifibatide
  • Clopidogrel
  • Cilostazol
  • Abciximab
  • Ticlopidine
  • At least 5 days or 5 half-lives since prior anticoagulants such as warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, enoxaparin)
  • At least 5 days or 5 half-lives since prior drugs accepted to have a risk of causing torsades de pointes, including the following:
  • Class IA antiarrhythmic agents (e.g., quinidine, procainamide, or disopyramide)
  • Class III antiarrhythmic agents (e.g., amiodarone, sotalol, ibutilide, or dofetilide)
  • Macrolide antibiotics (e.g., erythromycin or clarithromycin)
  • Antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, or pimozide)
  • Tricyclic antidepressants
  • Cisapride
  • Bepridil
  • Inapsine
  • Methadone
  • Arsenic
  • Concurrent anagrelide for thrombocytosis due to CML allowed

Who cannot join

  • extramedullary involvement (other than liver or spleen)
  • significant bleeding disorder unrelated to CML
  • acquired bleeding disorder within the past year (e.g., acquired antifactor VIII antibodies)
  • congenital bleeding disorders (e.g., von Willebrand disease)
  • uncontrolled or significant cardiovascular disease
  • uncontrolled angina within the past 6 months
Show all 27Show fewer
  • congestive heart failure within the past 6 months
  • myocardial infarction within the past 12 months
  • history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • history of second or third degree heart block (may be eligible if patient has a pacemaker)
  • diagnosed or suspected congenital long QT syndrome
  • prolonged QTc interval on pre-entry EKG (i.e., greater than 450 msec)
  • heart rate less than 50/minute on pre-entry EKG
  • uncontrolled hypertension
  • vasculitis
  • pregnant or nursing
  • gastrointestinal tract bleeding within the past 6 months
  • connective tissue disorders
  • other serious uncontrolled medical disorder or active infection that would impair the ability to receive study therapy
  • dementia or altered mental status that would preclude giving informed consent
  • evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EKG, or clinical laboratory determinations unrelated to CML
  • prisoners or patients who are compulsorily detained (e.g., involuntary incarceration for treatment of either a psychiatric or physical [e.g., infectious disease] illness)
  • concurrent drugs accepted to have a risk of causing torsades de pointes
  • other concurrent treatment for CML
  • concurrent dolasetron or droperidol
  • concurrent anticoagulants
  • concurrent medications that inhibit platelet function

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Phase I Dose-Escalation Study To Determine The Safety, Pharmacokinetics, And Pharmacodynamics Of BMS-354825 In The Treatment Of Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Hematologic Resistance To Imatinib Mesylate (Gleevec

RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate.
  • Determine the safety and tolerability of this drug in these patients.
  • Determine the plasma pharmacokinetics of this drug in these patients.
  • Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.

Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Once the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.

Conditions
Leukemia
Being tested
dasatinib
Keywords
chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startNov 2003
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064233
Sponsor's protocol ID
CDR0000310142
Other IDs
UCLA-0303035, BMS-CA180002
Status last verified
Aug 2012
First submitted
8 Jul 2003
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Cortes J, Sawyers CL, Kantarjian HM, et al.: Long-term efficacy of dasatinib in chronic-phase CML: results from the phase I trial (CA180002). [Abstract] Blood 110 (11): A-1026, 2007.

  • Talpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, Cortes J, O'Brien S, Nicaise C, Bleickardt E, Blackwood-Chirchir MA, Iyer V, Chen TT, Huang F, Decillis AP, Sawyers CL. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. doi: 10.1056/NEJMoa055229.

    PubMed 16775234

  • Talpaz M, Kantarjian HM, Paquette R, et al.: A phase I study of BMS-354825 in patients with imatinib-resistant and intolerant chronic phase chronic myeloid leukemia (CML): results from CA180002. [Abstract] J Clin Oncol 23 (Suppl 16): A-6519, 564s, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dasatinib in people with Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064233, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in